{"active_ingredient":["Active ingredient (in each rectal suppository) Acetaminophen 120 mg"],"ask_doctor":["Ask a doctor before use if your child has liver disease your child is taking the blood thinning drug warfarin"],"do_not_use":["Do not use if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist."],"dosage_and_administration":["Directions this product does not contain directions or warnings for adult use do not use more than directed remove wrapper carefully insert suppository well up into the rectum Dosing Chart Age Dose under 3 years Do not use unless directed by a doctor 3 to 6 years Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)"],"dosage_and_administration_table":["<table><col width=\"26%\"/><col width=\"60%\"/><tbody><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Dosing Chart</paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>Age</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Dose</paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>under 3 years</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Do not use unless directed by a doctor</paragraph></td></tr><tr><td styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>3 to 6 years</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)</paragraph></td></tr></tbody></table>"],"effective_time":"20240604","id":"1a15bc38-9384-1ded-e063-6394a90a647d","inactive_ingredient":["Inactive ingredient hydrogenated vegetable oil"],"indications_and_usage":["Uses temporarily reduces fever relieves minor aches, pains, and headache"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["ANDA070607"],"brand_name":["acetaminophen for children"],"generic_name":["ACETAMINOPHEN"],"manufacturer_name":["NuCare Pharmaceutiacals,Inc."],"original_packager_product_ndc":["45802-732"],"package_ndc":["68071-4151-1"],"product_ndc":["68071-4151"],"product_type":["HUMAN OTC DRUG"],"route":["RECTAL"],"rxcui":["198434"],"spl_id":["1a15bc38-9384-1ded-e063-6394a90a647d"],"spl_set_id":["5d7ef1d2-d970-7b01-e053-2991aa0a1311"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"],"upc":["0368071415117"]},"package_label_principal_display_panel":["Principal Display Panel PDP"],"purpose":["Purposes Pain reliever/fever reducer"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"5d7ef1d2-d970-7b01-e053-2991aa0a1311","spl_product_data_elements":["acetaminophen for children Acetaminophen COTTONSEED OIL ACETAMINOPHEN ACETAMINOPHEN"],"stop_use":["Stop use and ask a doctor if fever lasts more than 3 days (72 hours), or recurs. pain lasts more than 5 days or gets worse. new symptoms occur. redness or swelling is present in the painful area. These may be signs of a serious condition."],"storage_and_handling":["Other information store at 20-25 ° C (68-77 ° F) or in a cool place tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged."],"version":"6","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. For rectal use only Do not use if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if your child has liver disease your child is taking the blood thinning drug warfarin Stop use and ask a doctor if fever lasts more than 3 days (72 hours), or recurs. pain lasts more than 5 days or gets worse. new symptoms occur. redness or swelling is present in the painful area. These may be signs of a serious condition. Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms."]}